1. Field of the Invention
The present invention relates to practical stethoscope cover means and means for dispensing thereof, such that medical practitioners, at low cost and with minimal effort are enabled to minimize the chances of germ transmission via the stethoscope as a transmission means. In preferred embodiments of the invention, the stethoscope cover is dispensed in a single hand (left or right) action for covering a stethoscope cover. The stethoscope cover disclosed herein may also be applied to other medical and paramedical uses and devices, such as occluders used in ophthalmology.
2. Background Information
It appears to have been relatively widely recognized, as far back in medical science as the days of Dr. Semilweis that pathogens may be transmitted from one patient or one location to another via contact with physician""s hands, instruments, clothing and the like. In order to stem infectious disease in an African hospital, Dr. Semilweis instituted the revolutionary (for the time) requirement that every physician, between each patient, had to carefully wash his or her hands. The beneficial effect was immediate and spectacular.
The general term used in medical science to describe the effect whereby potentially pathogenic organisms, including but not limited to bacteria, viruses, proteins, and the like, are unwittingly transmitted from one patient or location to another is xe2x80x9cnosocomial infection.xe2x80x9d The means by which such organisms are transmitted are generally referred to a xe2x80x9cfomitesxe2x80x9d.
Medical science has advanced considerably since the days of Dr. Semilweis, and the need for cleanliness, and sterility of medical instrumentation has been generally accepted. However, in one particular area, there appears to be circumstantial evidence of nosocomial infection by a particular type of fomite: the stethoscope.
As is generally known and appreciated, the term xe2x80x9cstethoscopexe2x80x9d is generally applied to any instrument which a physician may utilize to amplify sounds produced by various portions of a patient""s body. Typically, as is still generally the case, a stethoscope comprises a single head:or a dual-headed device. Typically, the single headed device, or one of the heads of the dual headed device is an enclosed, cavernous xe2x80x9cbulbxe2x80x9d, wherein the enclosed bulb-comprises a taut diaphragm stretched across the opening of the bulb. In most dual head stethoscopes, the second head is merely a bell shaped device. To a port on each bulb is connected a tube, terminating in an earpiece, for insertion into the ear of a physician, nurse or other user of the stethoscope. The stethoscope operates by virtue of the taut diaphragm acting as an amplifying means for any sounds, vibrations and perturbations that occur at the surface to which the taut diaphragm is placed in contact. The combination of the cavernous bulb and the taut diaphragm is generally referred to as the stethoscope head. The amplified sounds travel from the stethoscope head, through the tube, and hence into the physicians"" ear, whereby certain diagnoses may be made by the physician.
In the medical arts, the danger of nosocomial infection via patient-to-patient contact of the same stethoscope head, either with or without intermittent disinfection of the stethoscope head, has been relatively widely recognized. Yet, to date, there does not seem to have been adopted a generally used, practical, simple, inexpensive and effective means for prevention of the stethoscope head acting as a fomite. Study after study in the medical literature proclaims this danger and the need for an effective means of combating this problem. In addition, multiple patents have issued in the United States and elsewhere, purporting to address and solve this serious problem. Yet, as must be emphasized, here, it does not appear that any practical, effective, and cost-effective means has yet been generally adopted to limit or eliminate this problem.
In order to briefly survey efforts that have been made to date to address this problem in the United States patent literature, a brief discussion follows on several issued United States patents in which various barrier means, containers and the like have been described, in an effort to address the above-identified problems. The following discussion is provided, in addition, such that by comparison with the to-date described stethoscope barrier means, the virtues and differentiating features of the present invention may be appreciated by counterpoint. To assist in identifying these distinctions, the following brief description of the practical stethoscope cover of this invention is first provided, which description is greatly expanded upon in the section of this disclosure entitled xe2x80x9cPREFERRED EMBODIMENTS OF THE INVENTIONxe2x80x9d, and in the claims which follow.
The practical stethoscope cover of this invention in its most essential elements, comprises any form of material which acts as an effective, inexpensive and acoustically transmissive barrier means for easy application and removal from the head, or heads, of a stethoscope. The barrier means should be non-transmissive for dirt, organisms, oils and the like, all of which may carry pathogenic components. Ideally, the barrier material is also soft and temperature insulating, such that the stethoscope cover when applied to the head of a stethoscope acts as a buffer against the shock of cold metal to skin contact. Significantly, embodiments of the stethoscope cover of this invention are easily applied by a physician, nurse or other medical practitioner to the head of a single or dual head stethoscope, typically in a quick, simple, easy single-handed operation. This invention comprehends at least two principal stethoscope cover designs. A first principal design comprises a stethoscope cover which can be used for a single head stethoscope, such that the diaphragm of the stethoscope can, in a single-handed operation, be slipped into a pouch formed from a material which will prevent contamination of the stethoscope head by microorganisms residing on the skin of a patient. The pouch design involves a unitary piece of a material to form a flat bottom portion and an overlapped top portion having an overlapped envelope and sealed sides. Described herein below are various modifications, variations, and additions to this basic design, along with a dispensing means for use in combination with this first principal design. A second principal design comprises a stethoscope cover which can be used on single and dual head stethoscopes. The edges of the diaphragm of either type of stethoscope can easily be slipped under retaining folds formed in the cover, securing the cover to the stethoscope, while the remaining elongate material is drawn over the bell, in the case of a dual head device, or over the back (top) of the single head device, thereby completely covering and insulating the stethoscope head(s) from contamination. Described herein below are variations, modifications and additions to this second principal design, along with dispensing means for use in combination with this second principal design. A greater appreciation of the details, various embodiments, and practicality of the instant invention will be achieved upon review of the below provided section entitled xe2x80x9cPREFERRED EMBODIMENTS OF THE INVENTIONxe2x80x9d, the provided drawings and the appended claims.
Having generally described the stethoscope cover of this invention, the reader""s attention is directed to the following United States patents in which various devices are described, with the intent of providing stethoscope covers.
U.S. Pat. No. 4, 871, 046 discloses and claims a disposable stethoscope head shield made form a unitary bottom portion and top portions which are connected to the bottom portion so as to define an envelope into which a stethoscope head may be inserted and an opening between the top portions through which the stethoscope head is introduced into the envelope. This stethoscope cover appears to be particularly suited only for single head stethoscopes and would appear to require more than a single hand for the stethoscope head to be inserted. Unlike the embodiments of the present invention, the device of the ""046 patent is visually and labor intensive to mount on a stethoscope head, and application of the cover exposes the cover to the user""s hands and other fomites. In addition, contamination from exposed portions of the ""046 cover are easily moved to the portion of the cover placed in contact with a patient. Furthermore, the ""046 device does not have an overlapped top portion to produce a top with an overlapped envelope nature. There is no description or suggestion of a permanent crease in the top portion to form a further sealed envelope portion. In addition, there is no description or suggestion of an attachment means, such as stiff or flexible rubber wings to be associated with the single headed stethoscope to assist the head in remaining securely within the pouch. Furthermore, the ""046 patent device, while allegedly being useable for application on the bell portion of a dual head stethoscope, in practice, if the opening of the ""046 device is large enough to allow entrance of the diaphragm portion, it appears that the cover would fall off of the bell portion. Finally, perforations on a roll of the ""046 patent covers implies that the care-giver must use both hands to separate a cover from adjoined covers, and both hands are required to mount the cover. This is time consuming, labor intensive and is almost guaranteed to result in transfer of contamination from the hands or gloves of the user to the patient contact surface of the cover. Accordingly, neither of the principle designs disclosed herein are disclosed by this patent.
Design Patent No. 344, 798 discloses the design of a cover for the head of a stethoscope. The appearance of the disclosed design is quite different from the appearance of the present stethoscope covers and does not appear to disclose or suggest the overlapping top feature or the permanent seam features of either of the principal designs disclosed herein. Because this is a design patent, it is unclear how this device operates, but in appearance it is quite distinct from the appearance of the device of the present invention.
U.S. Pat. No. 5,269,314 discloses a stethoscope cover intended largely to increase a patient""s comfort by preventing contact with the skin of a cold stethoscope head. The cover is made form a fabric having an elasticized hem. This stethoscope cover seems to be particularly suited for covering only a single head of a stethoscope and would appear to require more than a single hand for the stethoscope head to be inserted, thus increasing the risk of contamination. In addition, the described device does not have an overlapped top portion to produce a top with an overlapped envelope nature. There is no description or suggestion of a permanent crease in the top portion to form a further sealed means, such as stiff or flexible rubber wings to be associated with the single headed stethoscope to assist the head in remaining securely within the pouch.
U.S. Pat. Nos. 5,466,898 and 5,486,659 disclose elongated pouches into which the diaphragm and a portion of the stethoscope tubing may be inserted. Each of these patents disclose a form of catchment to retain the stethoscope head inside the bag (see FIGS. 3C and 4A-4C of the ""659 patent). However, neither of these patents disclose or suggest an overlapped, top portion having an overlapped envelope nature or a permanent crease in the top which can act as a catchment means for the head, nor a fold at the mouth for ease of entry and to act as a catchment for the diaphragm. The present invention inverts material of the sleeve back into the interior of the sleeve at the mouth, with the length of the top side of the sleeve being slightly shorter than the bottom. This design allows for facile, single-handed introduction of the stethoscope head into the cover. In addition, as a visual guide, the present invention may incorporate coloration, for example in the form of a line or the like on the inwardly inverted bottom portion of the mouth. Furthermore, neither of these patents disclose or suggest a design wherein contiguous pouches may be used to protect both heads of a two-headed stethoscope.
U.S. Pat. Nos. 4,867,265; 4,461,368; 4,867,268; 5,448,025 5,428,193; 5,424,495; 5,365,023; and 4,995,473 each disclose a stethoscope cover of one sort or another. However, none of these devices even begins to disclose or suggest the features of either of the principal designs outlined in this patent disclosure.
In U.S. Pat. No. 5,921,941 Issued Jul. 13, 1999xe2x80x94xe2x80x9cDisposable Stethoscope Coverxe2x80x9d, an elastomeric stethoscope cover for tensioned application to a single head of a stethoscope was described: The stethoscope cover of this patent cannot be applied to two heads of a stethoscope at the same time, and it appears that application would require use of two hands. Additionally, an elastic range sufficient to grip the diaphragm of most stethoscopes would be insufficient to keep the cover on the bell portion of the stethoscope.
U.S. Pat. No. 5,686,706 Issued Nov. 11, 1997xe2x80x94xe2x80x9cDispensable, Disposable cover for Stethoscopesxe2x80x9d, is a continuation-in-part of U.S. Pat. No. 5,424,495, wherein a shield with an adhesive backing is applied to the head of a stethoscope. Accordingly, this patent incorporates the problems of stethoscope head fouling inherent in any adhesively applied cover, which is a problem overcome and avoided by the present invention. In addition, due to the design of the ""706 patent device, acute visual attention is required to precisely place the cover on the stethoscope in order to ensure a xe2x80x9cbull""s-eyexe2x80x9d application. If the cover is not bull""s-eyed, an adhesive-fouled portion of the diaphragm is exposed to patient and other contaminant contact, resulting in unacceptably high germ loading of the stethoscope head. The accumulated high germ load is then passed from patient to patient when the cover is not mounted with precision.
In U.S. Pat. No. 5,949,032 Issued Sep. 7, 1999xe2x80x94xe2x80x9cStethoscope Cover and Covered Stethoscopexe2x80x9d, a plurality of adjoining flexible sheets of stethoscope covers in a stack. An adhesive is used to attach the covers to the stethoscope head and to retain the covers in a stack. There are various embodiments of the stethoscope cover defined in this patent, but none of these embodiments are intended for complete coverage of one or two headed stethoscope heads, as in the present invention.
In U.S. Pat. No. 5,747,751 Issued May 5, 1998xe2x80x94xe2x80x9cDisposable Cover for Stethoscope Headxe2x80x9d, a purportedly xe2x80x9cuniversalxe2x80x9d stethoscope cover is disclosed in the form essentially of a sack fashioned for receiving and retaining either a single or a dual head stethoscope. The patent acknowledges a number of prior art patents and discusses the improvement of the patented device in terms of the ability to easily apply the covering to any of a wide variety of stethoscope covers. However, the patent discloses only the sack-like embodiment of a stethoscope cover, without disclosing smaller, more tightly fitting stethoscope covers for single or dual head stethoscopes, as in the present invention. In addition, the ""751 patent does not appear to materially improve the ease of cover mounting, as it is awkward, time-consuming, visually intensive and requires use of both hands to place a single or dual head stethoscope in the sack.
In U.S. Pat. No. 5,564,431 Issued Oct. 15, 1996xe2x80x94xe2x80x9cFlexible Stethoscope Cover, Cover Package and Dispensing Systemxe2x80x9d, disclosed is an essentially xe2x80x9ccondom-likexe2x80x9d device for stethoscope heads, which is rolled over the head of the stethoscope. The xe2x80x9ccondomxe2x80x9d is described as having a pair of circular webs joined together by a side wall web. It appears that the device is a unitary, elastomeric device which is delivered stored within a sterile pouch. A disposable dispensing means is disclosed as part of the invention, but is adapted for dispensing the condom-like device within sterile, sealed packets which have to be torn open to release the condom-like device, which must then be unfurled over the stethoscope head. Accordingly, it is apparent that multiple steps and two-handed handling of the stethoscope cover is required.
U.S. Pat. No. 5,808,244 Issued Jul. 28, 1997xe2x80x94xe2x80x9cProtective Cover for a Contact Surface for a Stethoscopexe2x80x9d discloses and claims a protective cover for electrostatic adherence to a contact surface of a stethoscope head. There is no disclosure of a cover which encloses the stethoscope head, as in the instant invention.
U.S. Pat. No. 5,623,131 Issued Apr. 22, 1997xe2x80x94xe2x80x9cProtective Stethoscope Cover Having a Head Cover Connected to a Body Coverxe2x80x9d discloses a combination stethoscope head cover and stethoscope tube cover, which may be a unitary cover or which may be separated into two elements. The patent does not disclose stand-alone stethoscope head covers which may be applied in a single-hand application procedure for either a one or two-headed stethoscope, as in the present invention.
While the above identified patents are directed to the same general problem to which the present invention is directed, it is noted that there remains a need in the art for a practical, inexpensive and effective means for preventing nosocomial infections by stethoscope fomites. There does not appear to have been a general acceptance by medical practitioners of any of the above described patented devices, and it is believed that this is in large measure due to the impracticality of having to expend time, energy, and visual focus for precise placement to mount or remove the known stethoscope covers. In some of these devices, the head of the stethoscope, including the diaphragm, becomes fouled with adhesives used to retain the known stethoscope covers on the stethoscope head. As a result, the problem of stethoscopes acting as fomites is exacerbated, due to the xe2x80x9ctackxe2x80x9d residue imparted to the stethoscope heads through use of the adhesive stethoscope covers.
The present invention addresses and overcomes the above-identified limitations and meets the long-felt need of a practical, effective and inexpensive stethoscope cover device for prevention of nosocomial infections transmitted through stethoscope use.
The practical stethoscope cover of this invention in its most essential elements, comprises any form of material which acts as an effective, inexpensive and acoustically transmissive barrier means for easy application and removal from the head, or heads, of a stethoscope. The barrier means should be non-transmissive for dirt, organisms, oils, fluids and the like, all of which may carry pathogenic components. Additionally, it is desirable for the stethoscope cover to be aesthetically appealing, soft, and user and manufacturing friendly. It is also desirable for the cover to act as a temperature buffer such that it buffers shock of cold metal to skin contact.
Significantly, embodiments of the stethoscope cover of this invention are easily applied by a physician, nurse or other medical practitioner or user to the head of a single-head stethoscope or a dual-head stethoscope, typically in a quick, simple, easy single-handed operation. This invention comprehends at least two principal stethoscope cover designs. A first principal design comprises a stethoscope cover which can be used for a single head stethoscope, such that the diaphragm of the stethoscope can, in a single-handed operation, be slipped into a pouch formed from a material which will prevent contamination of the stethoscope head by microorganisms residing on the skin of a patient, or contamination of a patient with pathogens on the head of the stethoscope. The pouch design involves a unitary piece of a material to form a flat bottom portion and an overlapped top portion having an overlapped envelope and sealed sides, a xe2x80x9cpuffedxe2x80x9d mouth with at least one guide line for diaphragm insertion on the upper and/or lower lip of the cover. Described herein below are various modifications, variations, and additions to this basic design, along with a dispensing means for use in combination with this first principal design. A second principal design comprises a stethoscope cover which can be used for a single head or a dual head stethoscope, such that the stethoscope head(s) can easily be slipped into contiguous pouches formed from a material which will prevent contamination of the stethoscope head by microorganisms residing on the skin of a patient or contamination of a patient with pathogens on the head of the stethoscope. Described herein below are variations, modifications and additions to this second principal design, along with dispensing means for use in combination with this second principal design. A greater appreciation of the details, various embodiments, and practicality of the instant invention will be achieved upon review of the below provided section entitled xe2x80x9cPREFERRED EMBODIMENTS OF THE INVENTIONxe2x80x9d, the provided drawings and the appended claims.
Accordingly, it is one object of this invention to provide a novel, practical stethoscope cover.
It is a further object of this invention to provide a stethoscope cover which may be easily applied to a single headed stethoscope.
It is a further object of this invention to provide a stethoscope cover which may be easily applied to a dual-headed stethoscope.
It is a further object of this invention to provide a stethoscope cover which may be easily applied to a single or dual headed stethoscope.
It is a further object of this invention to provide means for retention of stethoscope covers on a stethoscope head without the need for two-handed application of the stethoscope cover.
Another object of this invention is to provide a means for facile dispensing of stethoscope covers.
It is a further object of this invention to provide a stethoscope cover comprising at least one crimp, gather or hinge.
Further objects and advantages of the invention will be appreciated from a review of the complete disclosure and the claims appended hereto.